Uncompromising Quality in Medical Device Testing
At European Biomedical Institute (EBI), quality is more than a certificate—it is the foundation of patient safety. Our laboratories operate under the world’s most stringent quality systems to ensure your results are valid, traceable, and globally accepted.
Our Global Accreditations
To provide the highest level of confidence to our partners, EBI maintains and continuously improves internationally recognized quality standards. Our compliance with ISO 10993-1:2018 (Section B.4.5.3) ensures that all testing supporting your biological evaluation is conducted within an appropriate quality framework.
GLP – Good Laboratory Practice
The Gold Standard for Non-Clinical Safety Studies
GLP is a quality system defining the rules and criteria for planning, performing, monitoring, recording, reporting, and archiving studies. At EBI, our GLP-certified process guarantees:
- Full Traceability: Every step of the study can be completely reconstructed.
- Data Integrity: Reliable results that support research or marketing permits for products regulated by global authorities.
- Global Acceptance: Studies conducted under GLP are recognized by the FDA, OECD, and other international bodies.
ISO/IEC 17025
Technical Competence & Valid Results
The ISO 17025 accreditation demonstrates that our laboratory operates competently and generates valid, reproducible results. It standardizes both technical requirements and management system protocols, ensuring:
- Competence of Staff: Highly trained specialists performing complex analyses.
- Equipment Calibration: Every instrument is maintained to international standards.
- Standardized Methods: Use of validated testing protocols for biocompatibility and chemistry.
US FDA 21 CFR Part 58 Compliance
Facilitating Entry to the U.S. Market
For manufacturers targeting the United States, compliance with the Code of Federal Regulations (21 CFR Part 58) is essential. EBI adheres to these practices to support applications for research or marketing permits, ensuring your submission meets the FDA’s rigorous non-clinical laboratory study requirements.
Regulatory Supervision & Inspections
Our laboratory doesn’t just self-regulate; we are subject to constant supervision and regular inspections by national and international governing bodies:
- Pharmaceutical Inspectorate
- Veterinary Inspectorate
- Ethics Committee
- Ministry of Science and Higher Education
- European Commission
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Access our current certifications and technical documents:
How We Work
Discovery & Insight
We begin with an in-depth consultation to understand your needs, challenges, and objectives. This helps us define the right strategy and scientific approach for your project.
Design & Development
Our experts translate your vision into actionable plans — combining innovative research, data, and technology to build precise and reliable solutions.
Delivery & Support
We implement the solution with full transparency and ongoing communication. After delivery, we stay involved — supporting you with optimization, updates, and future improvements.
Contact with us
We’re open to collaboration and research partnerships. Fill out the form — our team will respond as soon as possible.
Location:
Europejski Instytut Biomedyczny sp. z o.o.
ul. Bartycka 63A lok. 6, 00-716 Warszawa
Mail:
contact@ebi.bio
Phone:
+48 22 780 06 32
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